Abstract
The United States Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) Exemption for the boron-containing amino acid p-boronophenylalanine (EPA). The IND application was based upon preclinical studies carried out at Brookhaven National Laboratory that included: 1) the demonstration of selective accumulation of boron in a murine melanoma1; 2) the report of successful boron neutron capture therapy in a murine melanoma following BPA administration2; and 3) the toxicology/histopathology reports following oral administration of BPA to mice and rabbits3. The IND application also included a review and bibliography of the Japanese results with BPA both in animals and in humans. Originally approved for studies in patients with melanoma, the BPA IND was amended to include patients with glioblastoma or breast cancer following the report that BPA selectively delivered boron to tumors other than melanoma3.
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References
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© 1992 Springer Science+Business Media New York
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Coderre, J.A. (1992). A Phase 1 Biodistribution Study of p-Boronophenylalanine. In: Gabel, D., Moss, R. (eds) Boron Neutron Capture Therapy. Springer, Boston, MA. https://doi.org/10.1007/978-1-4615-3408-2_13
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DOI: https://doi.org/10.1007/978-1-4615-3408-2_13
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